FDA clears implantable contraceptive

By -
The Washington Times -
Tuesday, July 18, 2006

ASSOCIATED PRESS

Implantable contraceptives soon will be available again to U.S. women seeking a long-term solution to birth control, with the approval of a matchstick-size rod that can prevent pregnancies for up to three years.

Organon USA Inc. said yesterday that it would begin training doctors in August to implant the contraceptive rod, called Implanon. The Food and Drug Administration (FDA) approved the 11/2-inch-long rod late Monday. It is designed to be inserted underneath the skin of the upper arm.

Implanon provides 99 percent contraceptive protection. It will be the first contraceptive implant to be sold in the United States since 2000, when Wyeth Pharmaceuticals stopped U.S. sales of Norplant.

Norplant worked for up to seven years, but it spawned lawsuits by women injured while having its six rods removed or disturbed by side effects. Another implant, a two-rod product called Jadelle, received FDA approval in 1996 but has never been sold in the United States.

Implanon has been sold in more than 30 countries since 1998. More than 2.5 million women have used it, Organon said.

That track record, along with the implant’s single-rod design and the training doctors must receive before they can prescribe it to women, shouldn’t lead to a repeat of the Norplant experience, said Dr. Scott Monroe, acting director of FDA’s Division of Reproductive and Urologic Products.

In case of problems that lead to a recall, a card containing the implant’s lot number will be included in the medical files of women fitted with Implanon to help track them, Dr. Monroe said.

Implanon releases a low, steady dose of progestin to prevent pregnancy. Its use can cause irregular bleeding and spotting. For some women, it can eliminate monthly periods altogether.

The rod is inserted by a doctor under the skin of the upper arm in a quick surgical procedure that requires only a local anesthetic. It must be removed after three years, although it can be taken out at any time before then, said the company, a unit of Netherlands-based Akzo Nobel NV.

Progestin is a synthetic hormone similar to the progesterone made in the ovaries. The hormone typically acts on the body by thickening the mucus in a women’s cervix, preventing the union of sperm and egg. It also can prevent ovulation, or the release of an egg from the ovaries.

Implanon is associated with an increased risk of several serious side effects such as blood clots. Smoking can further increase those risks.

Organon did not release the price of Implanon. Spokeswoman Frances DeSena said it would be comparable on a per-month basis to the cost of other hormonal methods.

Its availability will be a benefit to women who want a method of birth control that doesn’t require a daily, weekly or monthly “ritual,” said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.

“The history of its use in other countries has indicated this is really a fantastic addition to the array of contraceptives available to women in this country,” Dr. Cullins said.